FDA.reportPublic FDA data

Application 210935

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50228-420FluoxetineFluoxetineScieGen Pharmaceuticals, IncANDACurrent
50228-420FluoxetineFluoxetineScieGen Pharmaceuticals, IncANDACurrent
50228-420FluoxetineFluoxetineScieGen Pharmaceuticals, IncANDACurrent
50228-421FluoxetineFluoxetineScieGen Pharmaceuticals, IncANDACurrent
50228-421FluoxetineFluoxetineScieGen Pharmaceuticals, IncANDACurrent
50228-421FluoxetineFluoxetineScieGen Pharmaceuticals, IncANDACurrent